Agenda eRA 2019

Day 1 - 22 May

subject to change

08:30 Registration and Networking Welcome Coffee

A1 Keynotes

09:00 Opening Address and Welcome - Maximilian Munte and Martin Schmid, Managing Directors, EXTEDO

  • We Listen to Your Feedback
  • Results RIMS Survey
  • Customer Success Project

09:30 Regulatory Telematics Panel -  Anjana Pindoria, Remco Munnik, Fakhredin Sayed Tabatabaei, Kevin Horan and Gary Wilson

10:00 Validating Artificial Intelligence in Regulatory - Klavs Esbjerg, Epista 

  • What is Artificial Intelligence and how can it create value in Life Science: Software as (or in) a medical device, AI in a computer system (EDMS, ERP), Research, and more
  • How is AI/machine learning related to data?
  • Why is it critically important to keep data in control?
  • What are the challenges, and solutions, when it comes to staying in control of data?
  • What kind of problems do we have when we want to verify the results?

10:30 Networking Coffee Break

A2 Telematics - Back to the Future

11:00 How Today's Telematics Will Shape the Way You Work Tomorrow. (SPOR, Target Operating Model, eAF, CESP and ePI) - Remco Munnik, ASPHALION 

  • Overview of the Telematics Strategy
  • Current status of ongoing programmes
  • Impact on the Industry

11:30 How ePI (electronic Product Information) Will Impact Your Regulatory Working – Fakhredin Sayed Tabatabaei, Medicines Evaluation Board Netherlands 

  • What is ePI: Product Information as a database?
  • Downstream: How ePI will improve Patient Safety?
  • Upstream: ePI and the facilitation of regulatory working

12:00 The Evolution of CESP – Kevin Horan, Bearing Point 

  • The birth of CESP
  • How CESP impacted the regulatory network
  • The Future of CESP

12:15 Simplifying Your Controlled Vocabularies – Gary Wilson, CorrIT

  • Approaching Master Data and Controlled Vocabulary Management
  • Choosing the correct implementation style for your organization
  • Establish strong data governance and drive data quality.

12:30 Introduction to the Interactive Sessions - Choose two of your favorite Barcamps

12:40 Networking Buffet Lunch

A3-D3 Barcamps Part 1

Barcamp A3

14:10 Submission Management in the Cloud

14:50 Submission Management in the Cloud

Moderated by Alexander Beck and Sven Pallarz, EXTEDO

Barcamp B3

14:10 Authorities and Industry – achieving mutual goals

14:50 Authorities and Industry – achieving mutual goals

Moderated by Schei Dattner, sales4u, Maren Müller and Michael Gessert, EXTEDO

Barcamp C3

14:10 Supporting the Collaboration between CRO and the Sponsor

14:50 Supporting the Collaboration between CRO and the Sponsor

Moderated by Kyle Stretch, EXTEDO and Remco Munnik, ASPHALION

CIS Session (in Russian)

14:10-17:30 Moderated by Inpharmatis

15:30 Networking Coffee Break

A4 Regulatory Updates and RIMS Implementation

16:00 Regulatory Update for the EAEU Region - Konstantin Koshechkin, Scientific Center for Expertise of Medical Application Products, Ministry of Health, Russian Federation

  • Regulation of digital submission for marketing approval of medicines in the Eurasian Economic Union
    • Legal regulation of the procedures in the Eurasian Economic Union
    • Market authorization and  medicines assessment rules in Eurasian Economic Union
    • Electronic submission of the dossier
    • Market authorization Procedure in the Russian Federation

16:30 Challenges and Best Practices on Asian Submissions - Simon Li, Molecular Science Center, Genetics Generation Advancement Corp. 

  • The regulatory environment in Taiwan, a South East Asia Country
  • What is the RA market strategy in Taiwan?
  • How Taiwan RA concur the global submission challenges?

17:00 Optimization of Regulatory Data by Implementing RImanager at Kern Pharma - Marta Gascon Moya and Beatriz Domínguez Pérez, Kern Pharma

  • The past: Decision for implementation of RIM solution
  • The current: Challenges and achievements
  • The future: Benefits and road ahead

17:30 End of Official Part Day 1

18:30 Evening Event (Boat Cruise on Lake Starnberg) and Dinner - meet in front of hotel for bus shuttle (included in all passes)